Syringe with a patient contact surface

ABSTRACT

A syringe and needle hub for a syringe has distal patient-facing side having a surface for contact with the subject&#39;s skin during injection. The contact surface is formed by a distal face of a post supporting a cannula and an outer collar surrounding the post. The axial distance between the distal face of the post and the distal face of the collar provided a contact surface with a radius of curvature to control the desired injection. The syringe barrel can have finger flanges extending outwardly where the flanges have a tactile member such as a dimple projecting from a proximal face of the flange and recess in a distal face of the flange.

This application claims priority to U.S. Provisional Application Ser.No. 62/320,058, filed on Apr. 8, 2016, which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The invention is in the field of injection medical devices fordelivering a medication or drug to a patient. Specifically the inventionis directed to a syringe or pen needle having a needle-bearing hub witha patient-contacting surface for improved injection performance. Thepatient contacting surface is configured for promoting the desired depthof penetration of the cannula into the skin. The hub can be integralwith the syringe barrel or can be installed on a medication pen used toadminister medications, but is not limited to use with such devices.

Description of the Related Art

A medication pen for delivering self-administered medications generallycomprises a syringe or a pen body, which houses a medicationcompartment, and a separate pen needle which may be attached to anddetached from the pen body. The syringe or pen needle includes aneedle-bearing hub having a recess on the proximal side for receivingthe pen body and a proximal (non-patient end) needle accessing themedication compartment, typically piercing the septum of a medicationcartridge in the pen body. The distal (patient-end) of the pen needleassembly includes the beveled distal end of the needle that is insertedinto the injection site.

Injections may be performed in the intradermal (ID) region, thesubcutaneous (SC) region and the intramuscular (IM) region. For manytypes of injectable medications, including insulin, the SC region ispreferred for administering an injection. See, for example, Lo Presti,et al., Skin and subcutaneous thickness at injecting sites in childrenwith diabetes: ultrasound findings and recommendations for givinginjection, Pediatric Diabetes (2012).

Different length needles, and with increasing frequency, shorter needlessuch as 4 mm and 5 mm needles, are adapted to achieve injection to aspecified target depth in a subcutaneous region. The present inventionaddresses the need to ensure that a needle is inserted to its targetdepth, regardless of the angle at which the user may approach theinjection site with the medication pen.

In certain prior art pen needles the cannula is supported in an axiallypositioned post on the hub. The post forms a narrow portion extendingdistally from the relatively wider portion in which the pen body isreceived. In other pen needles known in the art, a distal face of thehub placed against the injection site may be relatively large, and maybe provided with a slight taper at the edge. However, the edge of thehub engages the skin when the cannula is inserted at an angle,interfering with the injection.

While the prior devices are generally suitable for the intended use,there is a continuing need for improved devices for controlling thepenetration of a cannula for delivering a drug or medicament.

SUMMARY OF THE INVENTION

The present invention is directed to an injection device andparticularly to a syringe having needle hub with a skin contact surfaceconfigured for controlling the depth of penetration by a cannulaextending from the needle hub. The invention is particularly directed toa needle hub device where the contact surface has a height and widththat complement each other to control the depth of penetration of thecannula by providing a surface area sufficient to control the depth andshaped of the indentation in the skin under normal insertion forces.

The syringe of the present invention has a needle hub with a center postfor supporting a cannula and an outer collar or ring surrounding thepost. In one embodiment, the syringe is configured for dispensing smalldosages of the contents in the range of about 0.3 ml to 0.5 ml althoughthe volume can vary depending on the intended use of the injectiondevice. In other embodiments, the syringe can deliver a volume of about1 to 3 ml. The outer collar has a dimension to contact the surface ofthe skin during injection under typical insertion threes to control thedepth of penetration of the cannula into the skin. The post has a distalend that can be positioned relative to the distal end of the collar toprovide control in the depth of penetration of the cannula. The post canbe positioned substantially flush with the distal face of the collar. Inother embodiments, the distal end of the post can be spaced axiallyoutward from the distal face of the collar a distance such that thedistal face of the post and the distal face of the collar form a contactsurface for contacting the skin and providing a shape and contour tocontrol deformation of the skin when the cannula penetrates the skinduring use. The dimensions and location of the post relative to thecollar provide a skin contact surface having a dimension to distributethe force over the skin surface to reduce the incidence of the cannulapenetrating the skin deeper than intended.

In one embodiment the hub of the syringe has a distal face with adiameter in a range of 2.0 mm to 8.0 mm. The distal face of the post canextend beyond the distal face of the collar whereby the distance betweenthe distal face of the post and the distal face of the collar is about1.0 to about 5.0 mm and generally about 0.3 mm to about 2.0 mm. In otherembodiments, the distal face of the post can project from the distalface of the collar a distance of about 0.3 to 0.7 mm. In one embodiment,the distal end of the post can be aligned substantially flush with thedistal end of the outer collar or recessed with respect to the collar.

Another aspect of the invention is a syringe having a needle hubdefining a substantially convex skin contact surface defined by the postand the outer collar. The contact surface in one embodiment can have aheight of about of 0.3 to 0.7 mm a surface area of 1-4 mm².

One feature of the invention is to provide a syringe having a centerpost for supporting the cannula and an outer collar surrounding the postwhere the distal end of the post is recessed with respect to the distalface of the collar about 0.3 to 0.7 mm. The hub can have a diameter orwidth of about 2.0 to 8.0 mm to provide sufficient surface area and asuitable shape to provide the controlled depth of penetration by thecannula into the skin. The distance between the distal face of the postand the distal face of the collar allows the skin of the patient toenter the recess that is defined by the recessed post where the skincontacts the post and the face of the collar.

A shape of the needle hub of the syringe provides a greater surface areacontacting an injection site on a patient compared to a conventionalsyringe needle hub and controlling the depth of penetration of thecannula and reducing the occurrence of excessive penetration of thecannula. Greater patient comfort and stability are achieved as a resultof a larger surface area contacting the skin during injection.

The various aspects and features of the invention are basically attainedby providing an integral syringe comprising, a syringe barrel having anopen proximal end configured for receiving a plunger, and distal outletend. A post extends axially from said distal end of the syringe barrel,where the post has an axial passage communication with a cavity of thesyringe barrel. A cannula is received in the axial passage of the postand extends from the distal end of the syringe barrel, where the cannulahas a beveled distal end for injection into a subject's skin. An outerannular collar surrounds the post and extends axially from the distalend of the syringe barrel and defines an annular cavity between the postand the collar, where the collar has a distal end positioned relative tothe distal end of the post to contact the skin upon insertion of thecannula into the skin of the patient.

The features of the invention are further attained by providing asyringe, comprising a syringe barrel having a medication compartment, aproximal end having a plunger and a distal end having a hub. The hub hasan axially extending post with a distal annular face and an axialpassage receiving a cannula and communicating with the medicationcompartment. An axially extending annular collar surrounds the post andhas a distal annular face. The distal annular face of the post and thedistal annular face of the collar are configured for forming a skincontact surface to control deformation of skin of a patient whencontacting the skin with a normal insertion force and to control thedepth of penetration of said cannula upon insertion of the cannula intothe patient.

It will be understood that each of the preferred or optional features ofthe various embodiments may be combined with other features and featuresdescribed in combination with one or more particular features may alsobe combined with one or more other features of the other embodiments.

These and other features of the invention will become apparent from thefollowing detailed description of the invention, which in conjunctionwith the drawings disclose various embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following is a brief description of the drawing in which:

FIG. 1 depicts a standard syringe barrel having a needle hub protrudingfrom the end of the syringe barrel;

FIG. 2 is a cross sectional view of the needle hub of FIG. 1 ;

FIG. 3 is a perspective view of a syringe in a first embodiment of theinvention showing the post substantially flush with the end of thecollar;

FIG. 4 is an enlarge partial perspective view of the syringe hub of FIG.3 ;

FIG. 5 is a cross sectional view of the syringe hub of FIG. 3 ;

FIG. 6 is a cross sectional view of the syringe hub of FIG. 3 deformingthe skin by the penetration of the cannula;

FIG. 7 is a cross sectional view of a modified syringe hub;

FIG. 8 is a perspective view of a syringe hub in another embodiment ofthe invention;

FIG. 9 is a cross sectional view of the syringe hub of FIG. 8 ;

FIG. 10 is a cross sectional view of the syringe hub of FIG. 8 showingthe deformation of the skin during the penetration of the cannula;

FIG. 11 is a perspective view of the syringe hub in another embodimentof the invention;

FIG. 12 is a cross sectional view of the syringe hub of FIG. 11 ;

FIG. 13 is a cross sectional view showing the cannula insertion into theskin and the deformation of the skin;

FIG. 14 is a perspective view of another embodiment of the syringedevice;

FIG. 15 is a side view of the syringe of FIG. 14 ;

FIG. 16 is cross sectional view of the syringe of FIG. 14 ;

FIG. 17 is a top end view of the syringe of FIG. 14 ;

FIG. 18 is a bottom end view of the syringe of FIG. 14 ; and

FIG. 19 is a cross sectional side view of the syringe in a furtherembodiment.

DETAILED DESCRIPTION OF THE INVENTION

A syringe is used herein to refer to a device having a medicationcompartment and a cannula for delivering the medication, such asinsulin, to a patient. A pen delivery device typically contains multipledoses of medication, and a separate pen needle. The phrase “pen needle”refers to a needle-bearing assembly which can be attached to themedication pen body so that a proximal end of the pen needle assemblyaccesses a medication compartment and a distal end is adapted forinsertion into an injection site to perform one or more injections. Theterms “needle” and “cannula” can be used herein interchangeably. In oneembodiment, the cannula can be a member configured for insertion into aninjection site on a subject. One example is a cannula having a beveledend for insertion into the patient. As used herein, the “distal”direction is in the direction toward the injection site, and the“proximal” direction is the opposite direction. “Axial” means along orparallel to the longitudinal axis of the needle and the “radial”direction is a direction perpendicular to the axial direction.

The position of the subcutaneous layer in a subject's tissue and thedesired injection depth vary depending on the age of the patient, thepart of the body where the injection is administered, etc. Therefore, aninjection depth in absolute terms cannot be considered a critical aspectof the invention. In general, the intradermal (ID) layer in adults has athickness of around 2 to 3 mm, so that ID injection depth is in a rangeof about 3 mm or less, depth being measured from the outer surface ofthe skin. The subcutaneous (SC) region thickness can vary widelydepending on the location of the injection site on the subject's bodyand the subject's body mass index (BMI). The average thickness of the SCspace is in the range of about 7 mm to about 12 mm, so that SC injectiondepth is in a range of about 3 to 15 mm. The SC region may be furthersubdivided into the shallow subcutaneous (SSC) layer, having a thicknessof about 1 mm, and an injection depth of about 2 to about 4 mm, the SClayer having a thickness of about 4 mm, at a depth of about 3 to 7 mm,and the deep subcutaneous (DSC) layer, having a thickness of about 4 mm,and a depth of about 7 to about 12 mm. If injections from a device occurin the upper region of the subcutaneous space (SSC), it is more likelythat an ID injection will occur with that device. When injections from adevice occur in the deeper regions of the subcutaneous space (DSC), itis more likely that an IM injection will occur with that device. Insulinis preferably delivered to the SC space. Injections to either the ID orintramuscular (IM) space may result in different uptake of insulin fromwhat is prescribed.

The invention is directed to an injection device and particularly asyringe having a cannula with a predetermined length for penetrating theskin to a predetermined penetrating depth. The injection device has askin contact surface for contacting and deforming the skin when thecannula penetrates the skin to assist in controlling the depth ofpenetration at various angles of injection with respect to the surfaceof the skin. The contact surface has a predetermined shape, width, andheight to control the depth of penetration into the skin to the desiredlayer of the skin. In one embodiment, the contact surface having adiameter of about 3-4 mm provides a surface or contact area sufficientto prevent a deep indentation in the skin around the cannula when thedevice is pressed against the skin by a typical insertion force duringuse. The syringe can be, for example, a 0.3 ml syringe or a 0.5 mlsyringe although over sizes can be provided depending on the drug beingdispensed.

Referring to FIGS. 1 and 2 , a commonly used syringe barrel 10 has a hub12 with a post 14 projecting outward from the annular ring 16. The endface of the post is positioned from the outer ring 16 so that duringnormal use only the end of the post contacts the skin during theinsertion of the cannula. The end face of the post has a dimension wherea deep indentation is normally formed in the skin by the post contactingthe skin. The deep indentation formed in the outer surface of the skinoften results in the cannula penetrating deeper into the skin to skinlayers deeper than intended by the user. By way of example, a 4.0 mmcannula mounted in a post having a width of about 1 mm can result in thecontact surface forming a deep concave depression in the surface of theskin so that the cannula can penetrate the deeper than 4 mm andpenetrate the deeper layers of the skin that can cause pain ordiscomfort to the user. The deeper penetration can also cause thecannula to deliver the drug to layers of the skin that are lesseffective in delivering the drug to the patients and increase the riskof intramuscular injection, particularly in pediatric patients.

In the invention, the skin contact surface of the syringe hubsurrounding the cannula has a width and height configured for providinga larger surface area and greater control of the depth of penetration bythe cannula. In one embodiment of the invention, the pen needle deviceis configured to obtain a cannula penetration of about 4 mm. The skincontact surface is further configured to control the shape, width anddepth of deformation of the skin surface when the device is pressedagainst the skin during the penetration of the cannula. The width isdetermined as being the surface area defined by the outer peripheraledge that contacts the skin during the insertion of the cannula andduring the injection or delivery of the drug using a normal insertionforce. The height refers to the linear distance between the outerperipheral edge of the contact surface and the proximal end of thecontact surface.

The skin contact surface in one embodiment of the invention can have asubstantially convex shape, a substantially flat face, or concave facethat contacts the skin during penetration of the cannula and delivery ofthe drug. The contact area can have a width or diameter of greater than3.0 mm and typically about 4.0 mm. The contact area in one embodimentcan have a substantially annular or circular shape. The width of thecontact area refers to the diameter or transverse dimension of the outerperipheral edge as indicated by arrow 59 in FIG. 5 . The contact areacan be flush or can have height or depth of about 0.5 to about 1.5 mmmeasured from the outer peripheral edge of the contact surface to thecontact surface of the post.

In the embodiment of FIGS. 3-7 , the syringe 20 includes a syringebarrel 22 having an open proximal end 24 and a distal end 26. Aninternal axial cavity 28 shown in FIG. 5 receives the medicament to bedelivered to the patient. The open proximal end 24 receives a plunger 30for dispensing the contents of the syringe. A hub 32 extends axiallyfrom the distal end 26 for supporting a cannula 34 and defining the skincontact area.

The hub 32 shown in FIGS. 4 and 5 has a center post 36 extending axiallyfor supporting the cannula 34. As shown in FIG. 5 , the post 36 has anaxial passage 38 communicating with the cavity 28 of the syringe barrel22. The cannula 34 is mounted in the axial passage 38 and attached by asuitable adhesive 40 as shown in FIG. 5 . The cannula 34 has alongitudinal length to penetrate the skin to the desire depth. Thedistal end of the axial passage 38 has a conical shape that flaresoutward toward the peripheral edge of the post to define a recess 42 forreceiving the adhesive 40. In the embodiment show, the adhesive 40 fillsthe conical recess 42 so that axial end of the post is substantiallyflat and the adhesive does not protrude outward from the face of thepost 36. The distal end face 44 of the post 36 in the embodiment shownhas a substantially flat surface oriented in a plane substantiallyperpendicular to the longitudinal axis of the syringe and the cannula34. The distal end face 44 in the embodiment shown has an annularconfiguration and narrow radial width relative to the diameter of thepost 36. The adhesive 40 fills the recess 42 so that the adhesive issubstantially flush with the peripheral edge of the post 36 to form aflat distal surface 46 for contacting the skin during the insertion ofthe cannula into the patient.

The hub 32 includes an outer annular collar 48 forming a sleeve or ringsurrounding the post 36. The collar 48 is concentric with the post andspaced radially outward from the post 36 to define an annular recess 50.In the embodiment shown, the annular recess 50 extends from the proximalend of the collar 48 and the proximal end of the post 36 and extendsbetween the outer surface of the post 36 and the inner surface of thecollar 48. The radial dimension of annular recess 50 can be about 0.5 to3 mm and typically about 1.0 mm.

The collar 48 has a distal face 52 forming an annular shaped skincontact surface spaced outward from the distal surface of the post 36.In the embodiment shown, the distal face 52 is substantially flat and iscoplanar with the plane of the distal face 44 of the post 36. Distalface 52 has a slightly rounded peripheral edge 53 to provide a level ofcomfort to the patient during use. The distal face 44 of the post 36 andthe distal face 52 of the collar 48 define a skin contact surface whenthe cannula is inserted into the patient. The distal face 52 of thecollar 48 defines the outer dimension of the skin contact surface. Theorientation and dimension of the collar 48 are provided to contact theskin of the patient under a typical insertion and injection force and todistribute the force over an area to control the depth of penetration ofthe cannula into the skin.

Referring to FIG. 6 , the cannula 34 is inserted into the patient topenetrate the skin to the desire depth. The collar 48 has a diameter todisperse or distribute the penetration force over a larger surface areaof the skin to limit the inward deforming or depression of the skincompared to the prior syringe where only the post supporting the cannulaengages the skin that forms a deep depression or indentation in the skinresulting in a deep penetration of the cannula. The distal face 44 ofthe post 36 and the distal face 52 of the collar 48 define asubstantially flat contact surface to distribute the force over asufficient surface area to control the depth of the indentation formedby the penetration force as shown in FIG. 6 .

The initial penetration of the cannula by the contact of the hubprojecting from the syringe barrel with the skin of the patient forms adepression in the skin and an initial cannula penetration depth. Thesurface of the skin then relaxes as shown in FIG. 6 so that the surfaceof the skin conforms substantially to the shape of the contact surfaceand limits the depth of penetration of the cannula. The invention isdirected to the shape, surface area and height of the contact surface toprovide control of the depth of penetration of the cannula during theinsertion and penetration force being applied to the injection device.

The cannula in the embodiment shown can have a length of about 4.0 to6.0 mm to penetrate the skin to the desired depth for the efficientdelivery of the drug and, particularly insulin. In other embodiments,the cannula can have length of about 3.5 to about 8.0 mm. In stillfurther embodiments, the cannula can have a length of about 2.5 to 6.0mm and generally about 4.0 to 5.0 mm. The cannula can be, for example, a31 gauge or 32 gauge although other gauges can be used. The contactsurface of the hub has a width and height to control the deformation anddimension of the indentation in the skin and distribute the injectionforce across a sufficient area thereby controlling the depth ofpenetration of the cannula. The shape and dimension of the contactsurface distribute the applied pressure upon full engagement to the skinsurface. The contour in combination with the pressure distributionprovides improve comfort to the patient. The height and surface area ofthe hub and the perimeter surface area influence the degree ofcompression and relaxation of the tissue for a given application force.

The dimensions of the hub can vary depending on the desired depth ofpenetration of the cannula and the length of the cannula. The collar hasan axial length indicated by arrow 58. The collar can have a length ofabout 5.0-7.0 mm and typically about 6 mm. The collar can have adiameter indicated by arrow 59 of about 4.0 to 10.0 mm, generally about3.0-5.0 mm and typically about 4.0 mm. The post 36 can have a diameterof about ⅓ the outer diameter of the collar. The post can have adiameter of about 1.0 to 2.0 mm.

In another embodiment shown in FIG. 7 , the post 36 can have a deeprecess 54 at the distal end of the axial passage 38 to receive theadhesive and secure the cannula 34 to the post. In this embodiment, therecess 54 is sufficiently deep to allow the adhesive 40 to be recessedwith respect to the distal end of the post and form a recess 56 aroundthe cannula 34.

FIGS. 8-10 show an alternative embodiment of a syringe 60 having asyringe barrel 62 and a hub 64 for supporting the cannula 66. The hub 64is formed by a center post 68 and an outer collar 70. The post 68 as inthe previous embodiment has a substantially cylindrical shape thatextends axially from the distal end of the syringe barrel. The post 68has an axial passage 72 for receiving the cannula 66 and adhesive 74 tosecure the cannula 66 to the post 68. The distal end of the post and theadhesive 74 define the distal face of the post for contacting the skinduring the insertion of the cannula into the patient. In the embodimentshown, ribs 69 extend between center post 68 and outer collar 70 tostabilize the post 68 and cannula 66. As shown, ribs 69 have a distalend spaced inwardly from the distal end of post 68.

The collar 70 has a cylindrical shape surrounding the post and extendsfrom the distal end of the syringe barrel to define an annular recess71. The annular recess 71 can have a radial width of about 1-3 mm. Thecollar 70 has distal surface 76 forming an annular skin contact surface.In the embodiment shown, the distal surface 76 has a substantially flatcontact surface oriented in a plane parallel to the plane of the distalface of the post and substantially perpendicular to the longitudinalaxis of the cannula. The collar has an outer peripheral edge 77 that isrounded or curved to form a smooth transition between the distal faceand the side surface of the collar. The distal surface 79 of the post 68is recessed with respect to the distal surface 76 of the collar to forma slight recess 81. As shown in FIG. 10 , the recess 81 formed by theposition of the distal surface of the post 68 relative to the distalsurface of the collar 70 allows the skin 83 of the patient to deforminto the recess 81 during the insertion of the cannula into the skin ofthe patient. The distal surface of the post and the distal surface ofthe collar form the skin contact surface and have a radius to define asurface area to control the depth of the indentation in the skin underthe insertion force. FIG. 10 shows the deformation of the skin duringinsertion of the cannula where the depression in the skin conformssubstantially to the shape of the contact surface of the post and thecollar.

In one embodiment, the axial spacing between the distal face 76 ofcollar 70 and the distal face 79 of post 68 can be about 1.0 to 1.5 mmand generally about 0.3 to 0.7 mm. The axial spacing between the distalface 76 of collar 70 and the distal face 79 of post 68 defines the depthof recess 81. The diameter of the inner edge of collar 70 defines thewidth of access 81.

FIGS. 11 to 13 show another embodiment of a syringe 80 having a syringebarrel 82 and a hub 84 supporting a cannula 86. The hub 84 has a centerpost 88 for receiving the cannula 86 and a conical shaped recessed endreceiving the adhesive 90. As in the previous embodiment, the adhesivefills the recess in the end of the post 88 to form a substantially flatdistal face 92 of the post 88. An outer collar 94 surrounds the post 88to define an annular recess 96 between the post 88 and the collar 94.Annular recess 96 can have a radial width extending between the innerface of collar 94 and outer face of post 88 of about 0.5 to 3.0 mm andtypically about 1.0 mm.

In the embodiment of FIG. 12 , the post 88 has an axial length greaterthan an axial length of the collar 94 so that the distal surface 92 ofthe post 88 is spaced axially outward from the distal surface 96 of thecollar. As shown in FIG. 13 , the post 88 is spaced from the collar adistance so that the distal surface of the post and the distal surfaceof the collar define a skin contact surface during the insertion of thecannula. The distal surface of the post produces a depth of theresulting indentation greater than the depth of the collar and providesa smooth substantially concave curvature of the skin indentation asshown in the FIG. 13 . The skin deformation is caused by the insertionforce during the insertion and penetration of the cannula using aninsertion force normally applied by the patient. In one embodiment, thedistal face 92 of post 88 can extend axially from the distal face ofcollar 94 a distance of about 0.3 to 0.7 mm. In the embodiment shown,the post 88 and collar 94 form a substantially convex curved skincontact surface. The post 88 can extend from the collar a distance toprovide, for example a skin contact surface with a radius of curvatureof about 6.0 to 10.0 mm.

The distal contact face of the hub can have various configurations forproviding the desired control for the depth of penetration of thecannula. In each embodiment, the distal contact face has a width ordiameter to provide a sufficient surface area and height defined by thecurvature of the contact face to minimize the depressing of the skinthat can cause the cannula to penetrate the skin deeper than intended.

In various embodiments, the post can have a diameter of about 1.0-3.0 mmand generally about 1.0-1.5 mm. The post can have a height of about1.0-1.5 mm as measured from the outer periphery of the contact surfaceof the collar. The ratio of the diameter (D) of the post to the axialspacing between the distal face of the post and the distal face of thecollar can range from about 2:1 to about 4:1 and generally about 2.5:1to 3:1. The larger ratio provides a greater surface area that providesincreased comfort to the patient and greater control of the insertiondepth.

Referring to FIGS. 14-18 a further embodiment of the injection device isshown including a syringe barrel 100 having a distal end 102 andproximal end 104. Distal end 102 is similar to the embodiment of FIGS.2-6 and includes an outer collar 106, an inner post 108 and radiallyribs 110 extending between the inner surface of the outer collar 106 andthe outer radial surface of the post 108. As shown in FIG. 16 , the ribs110 have a distal end 112 spaced from the ends of the collar 106 and thepost 108. In this embodiment, collar 106 has an annular distal face 114oriented in a plane substantially perpendicular to the longitudinal axisof the syringe barrel 100. Inner post 108 has a distal annular face 116oriented in a plane substantially perpendicular to the longitudinal axisof the syringe barrel. In the embodiment shown, the distal face 116 ofpost 108 is oriented in the same plane as the distal face 114 of collar106. A longitudinal passage 118 extends through post 108 for receivingand supporting a cannula 122 and communicating with the internal chamber120 of syringe barrel 100. The cannula 122 is attached to the post 106by an adhesive as in the previous embodiment and has a length and widthas in the previous embodiments.

The proximal end 104 of syringe barrel 100 has an open end 124 forreceiving a plunger (not shown) for dispensing the contents of thechamber 120 in the usual manner. In the embodiment shown, the proximalend 104 of the syringe barrel 100 has an axially extending collar 126for receiving the operating end of the plunger.

Flanges 128 extend radially outward from opposite sides of the proximalend 104 between syringe barrel 100 forming finger grips or fingerflanges for the user to operate the device and deploy the plunger duringuse. In one embodiment as shown in FIG. 15 , the flanges 128 aresubstantially the same and mirror images of each other to extend outwardfor gripping the device by the user. In other embodiments, the flangescan be asymmetrical with different shapes, sizes and orientations toprovide the desired tactile feel to assist the user in gripping andmanipulating the device. The flanges 128 have distal surface 130 and aproximal surface 132. In the embodiment shown, the flanges 128 curveaway from the distal end of the syringe barrel 100 to form asubstantially concave surface of proximal surface 132. In alternativeembodiments, the flanges can curve in the opposite direction toward thedistal end of the syringe. As shown, the flanges 128 have curvature toprovide an ergonomic grip and distinctive feel to increase conform tothe user's fingers comfort of use. The ergonomic shape and conformationof the flanges 128 provide increased comfort and tactile confirmationthat makes holding and handling of the syringe easier for people withdexterity issues, such as arthritis and neuropathy that can occur indiabetes patients. In other embodiments, one or both flanges can curvetoward the distal end or can be straight and substantially flat.

In one embodiment, flanges 128 are provided with a tactile conformationto assist the user during deployment of the plunger and delivery of thesubstance. The tactile conformation can be on one or both flanges and oneither or both distal surface and proximal surface. In the embodimentshown, a dimple 134 is formed in the flanges 128 to extend from theproximal surface of the flanges. In the embodiment shown, the dimple 134is oriented toward the outer edge 136 of flange 128 forming a smoothcurved portion 128 between the dimple 134 and collar 126. In otherembodiments, the dimple can be positioned in the center or otherlocations of the flange surface or surfaces. Dimple 134 in theembodiment shown has a substantially convex, domed, tear drop shapewhere the outer edge 138 of the dimple is formed at the outer edge of136 of the flange 128. Alternatively, the dimple can have other shapes,such as a rounded or oval shape. The dimple 134 has a width, length, andheight sufficient to provide a tactile feel to assist the user inpositioning and holding the syringe. In other embodiments, the dimplesor other tactile member can be spaced inwardly from the end of theflanges and provided in other suitable orientations. In one embodiment,the dimples can extend the width or length of the flanges and providedon one or both surfaces of the flange.

Ridges 140 can be provided on the face of the dimple 128 to provide anadditional tactile feel. In the embodiment shown, the ridges extendacross the outer face of the dimple 134 and positioned toward the outeredge relative to the convex surface of the dimple 134. The ridges can beoriented to extend radially outward on the outer and/or inner surface ofthe dimples. In other embodiments, recess or other tactile conformationscan be provided on the dimples in place of projecting ridges.

The dimple 134 forms a concave recess 142 on the distal surface 130 ofthe flange 128 as shown in FIG. 18 . The recess 142 can also have one ormore ridges or recesses in the surface to provide a tactile feel. Asubstantially U-shaped open portion 144 is formed along the outer edgeto form a recess along the outer edge 136 to provide a tactile feel forthe user. A detent 146 forming a projection is formed in the concavesurface of the recess 142 that projects toward the distal end of thesyringe barrel 100. As shown in FIGS. 16 and 18 , ridges 148 can beformed adjacent the detent 146 to extend across the width of the concaverecess 142. The detent 146 and ridges 148 provide an additional tactilefeel for the user to assist in holding and positioning the syringebarrel. In other embodiments, ridges can provided to extend across theentire surface of proximal surface, the distal surface or both thedistal and proximal surfaces.

In the embodiment shown, the dimples project from the proximal surface.In alternative embodiments, the dimples can project from the distalsurface to form a recess on the proximal surface. In other embodimentsother tactile conformation or members can be provided on the proximaland/or distal surfaces to assist the user in positioning andmanipulating the syringe. In a further embodiment shown in FIG. 19 , theflanges 128 curve toward the distal end of the syringe. The elements ofthe embodiment of FIG. 19 are identified by the same reference numbersfor consistency. In the embodiment of FIG. 19 , the dimples 140 areshown projecting from the distal surface of the flanges toward thedistal end of the syringe. The recesses 136 are shown being formed onthe proximal surface of the flanges. In further embodiments, the dimplesor other tactile member can project from the proximal surface of one orboth flanges or from the distal surface of one or both flanges. In asimilar manner, one or more recesses can be formed on one or bothflanges on the proximal surface, the distal surface or both proximal anddistal surfaces.

The dimples 134 in the flanges 128 are shown in connection with theembodiment where the inner post 108 has an axial length substantiallythe same as the axial length of the collar 106. The dimples 134 can alsobe included in the embodiment of FIGS. 3-7 and the embodiment of FIGS.8-10 where the post 68 has an axial length less than an axial length ofthe collar 70 and in the embodiment of FIGS. 11-13 where the post 88 hasan axial length greater than an axial length of the collar 94 to providethe desire tactile feel to the syringes during use.

The above description of the preferred embodiments is not to be deemedas limiting the invention, which is defined by the appended claims. Thedisclosure is intended to enable the artisan of ordinary skill topractice variants of the invention described without departing from thescope of the invention. Numerical limitations herein, in thespecification and in the claims, are understood to be limited by themodifier “about,” such that minor departures yielding equivalent resultsis within the scope of the invention. Features or dependent claimlimitations disclosed in connection with one embodiment or independentclaim may be combined in another embodiment or with a differentindependent claim without departing from the scope of the invention.

What is claimed is:
 1. An integral syringe comprising, a syringe barrelhaving an open proximal end receiving a plunger, and distal outlet end;a post extending axially from said distal end of said syringe barrel,said post having an outer diameter of 1.0 to 2.0 mm and an axial passagein communication with a cavity of said syringe barrel and a distal endface; a cannula received in said axial passage of said post andextending from said distal end of said syringe barrel, said cannulahaving an exposed length of about 4.0 to 6.0 mm for injection into asubject's skin; an outer annular collar surrounding said post andextending axially from said distal end of said syringe barrel anddefining an annular recess between said post and said collar, saidcollar having a distal end face positioned relative to said distal endface of said post a distance to contact the skin upon insertion of saidcannula into the skin of the patient, whereby said distal end face ofsaid collar and said distal end face of said post form a continuouscurve having a radius of curvature of about 6.0 to about 10.0 mm tocontact the skin and provide a controlled deformation of the skin forinserting the cannula to a selected depth, said syringe barrel, post andouter annular collar defining an integral, one-piece syringe; whereinsaid distal end face of said post is spaced axially outward from saiddistal end face of said collar a distance of about 0.3-0.7 mm wherebysaid distal end face of said post and distal end face of said collardefine a skin contact surface, and where said skin contact surface has adiameter of about 3.0-4.0 mm, wherein said distal end face of said posthas a radial width to contact the surface of the skin during insertionof the cannula into the skin of the patient, and said distal end face ofsaid collar has an axial face oriented with respect to said post wherebysaid distal face of said post and said distal end face of said collarform a skin contact surface with a configuration to distribute aninsertion force and to control deformation of the skin upon insertion ofthe cannula into the patient, wherein said syringe barrel furtherincludes at least one flange extending radially outward from a proximalend of said syringe barrel for gripping by a user, said flange having aproximal surface with at least one tactile member, and a distal surfacewith at least tactile member, said tactile member on said proximalsurface of said flange is a dimple projecting outward from said proximalsurface and where said tactile member on said distal surface is arecess, and said at least one recess in said distal surface includes aprojecting detent.
 2. The syringe according to claim 1, wherein saiddistal end face of said post is substantially flat and oriented in aplane substantially perpendicular to a longitudinal axis of said syringebarrel.
 3. The syringe according to claim 2, wherein said distal endface of said collar is substantially flat and has an outer edge with aconvex rounded profile, said flat surface extending between said outeredge and an inner edge where said flat surface is substantially parallelto said flat surface of said post.
 4. The syringe according to claim 1,wherein said axial passage of said post has a conical shaped recess atsaid distal end of said post, and where an adhesive is received in saidrecess to attach said cannula to said post and where said adhesive issubstantially flush with said distal end face to form a flat endsurface.
 5. A one-piece integrally formed syringe, comprising: a syringebarrel having a medication compartment, proximal end having a plungerand a distal end having a hub, said syringe barrel has an outwardlyextending flange at a proximal end for gripping by a user, said flangehaving a proximal face with a tactile member formed by a projectingdimple, and a distal face with a tactile member formed by a recess witha distally projecting detent opposite said projecting dimple; said hubhaving an axially extending post integrally formed with said syringebarrel, said post having a distal end face and an axial passagereceiving a cannula and communicating with said medication compartment,and an axially extending annular collar surrounding said post andintegrally formed with said syringe barrel and having a distal end face.6. The syringe according to claim 5, wherein said distal end face ofsaid collar has an outer peripheral surface at a peripheral edge and asubstantially flat annular area extending between said peripheral edgeand an inner edge of said collar, and where said distal end face of saidpost and said distal end face of said collar are oriented insubstantially the same plane, whereby said distal end face of said postis flush with said distal end face of said collar.
 7. The syringeaccording to claim 5, wherein said distal end face of said post isspaced axially outward from said distal end face of said collar adistance of about 0.5-1.5 mm whereby said distal end face of said collarand said distal end face of said post are positioned to define a skincontact surface, said annular collar having an outer dimension of about3.0 to 5.0 mm, and said post having an outer diameter of about 1.0 to2.0 mm.
 8. The syringe according to claim 5, wherein said distal endface of said post is spaced axially inward from said distal end face ofsaid collar a distance of about 0.5-1.5 mm to define a recessed area,and where said distal end face of said collar and said distal end faceof said post are positioned to define a skin contact surface.
 9. Thesyringe according to claim 5, wherein said axial passage of said posthas a conical shaped recess at said distal end face of said post and anadhesive received in said conical shaped recess to fix said cannula tosaid post, and where said adhesive has an outer surface that issubstantially flush with said distal end face of said post.
 10. Anintegral one-piece syringe comprising, a syringe barrel having an openproximal end with a plunger, and distal outlet end with a hub extendingfrom said distal end of said syringe barrel, said syringe barrel havingat least one outwardly extending flange at said proximal end, saidflange having a distal surface with a tactile surface including a recesswith a distally extending projecting detent; a post extending axiallyfrom said distal end of said syringe barrel, said post having an axialpassage communication with a cavity of said syringe barrel and receivinga cannula, said post having a substantially annular distal end face witha dimension for contacting the skin of a patient during insertion of thecannula; an outer annular collar surrounding said post and extendingaxially from said distal end of said syringe barrel and defining anannular cavity between said post and said collar, said collar having adistal end face positioned relative to said distal end face of said posta distance to define a skin contact surface to contact the skin upon aninsertion force applied to said syringe barrel and insertion of saidcannula into the skin of the patient, whereby said distal end face ofsaid collar and said distal end face of said post provide a skin contactsurface sufficient to contact the skin and distribute the insertionforce across the skin to provide a controlled deformation of the skinand inserting the cannula to a selected depth.
 11. The syringe accordingto claim 10, wherein said flange has a proximal surface with at leastone tactile member projecting from said proximal surface.
 12. Thesyringe according to claim 10, wherein said tactile member on saidproximal surface is a projecting dimple, and said tactile member on saiddistal surface is a recess oriented opposite said dimple.